FDAClass IIFebruary 3, 2016

Ascorbic Acid 500mg/syringe recall: Sterility Concern

ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.

Why was Ascorbic Acid 500mg/syringe recalled?

Lack of Assurance of Sterility: Product sterility cannot be guaranteed.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 27-Sep-15

Product
ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176.
Recalling firm
Sentara Enterprises
Quantity
7 Syringes
Distribution
U.S. Including: VA, NC
Recall date
February 3, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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